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Isoaid, LLC
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ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA is an FDA 510(k)-cleared medical device (K091117) manufactured by Isoaid, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2009. Regulation: 8.